Vivos Inc (RDGL)

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The goal of FDA Breakthrough Devices Program is to get potentially life-saving or life-improving innovative medical technologies into the hands of patients and healthcare providers faster.

These are called Sprint Discussions

Sprint discussions are a series of discussions held on a specific topic within the time period set by the sponsor (aka you). These discussions allow for rapid and repeated interactions with FDA about a single topic. Because FDA hopes to engage with breakthrough device designees early and often, the goal of sprint discussions is to reach an agreement in a shorter time frame than would occur by a typical pre-submission process.